HDS Plus PBPC Transplant Vs 4 More Courses of FrontLine Therapy in Pts With Aggressive NHL in PR After Induction Therapy

• Status: Completed
• Trial end date: 2008-04-01
• Target enrollment: 0
• Participant gender: All

Summary

The study is planned to compare the outcome of aggressive NHL patients in partial remission after four courses of front-line therapy, randomly assigned to receive either additional four courses of the same regimen or a modified HDS program.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gruppo Italiano Studio Linfomi

Criteria

Inclusion Criteria:

• Newly diagnosed, untreated patients with histologically documented aggressive lymphoma;

• Age between 18 and 65 years;

• Clinical stage at diagnosis: I A bulky - IV B;

• Reduction of tumoral masses, after four courses of induction therapy, between 50 and 75%;

• Serum negativity for HIV, HbsAg and HCV;

• ECOG performance status 0 through 4;

• Adequate bone marrow function;

• Adequate renal and hepatic functions;

• Left ventricular ejection fraction (LVEF) > 50%;

• No previous malignant disease;

• No previous chemo-radiotherapy;

• No cerebral or CNS involvement, assessed by clinical history, physical examination and CSF examination through lumbar puncture;

• Written informed consent given at time of randomization.

Exclusion Criteria:

• Clinical stage I no bulky, or CS IIA-B with less than three sites of disease involved;

• Patients with CR, unconfirmed complete remission (uCR), very good PR (>75%) and clinical response less than 50%, as defined by Cheson et al., following four courses of induction therapy;

• Tumor involvement of CNS (except patients with peridural masses without liquor involvement , who can be enrolled in this study);

• Indolent lymphoma transformed in more aggressive histologic type, even if never previously treated;

• Aggressive non-Hodgkin's lymphoma in pre-transplanted patient;

• Clinically significant secondary cardiovascular disease e.g. uncontrolled hypertension, (resting diastolic blood pressure > 115 mmHg), uncontrolled multifocal cardiac arrhythmias, symptomatic angina pectoris or congestive cardiac failure NYHA class III-IV;

• Left ventricular ejection fraction (LVEF) < 50%;

• Evidence of any severe active acute or chronic infection;

• Concurrent malignancy of history of other malignancy, except basal cell carcinoma of the skin (BCC) and in situ cervical carcinoma (CIN);

• myelodisplastic syndrome;

• HbsAg, HIV-positive, or HCV-RNA-positive patients;

• Patient with psychiatric, or any disorder that compromises ability to give truly informed consent for participation in this study;

• Pregnant woman; potential child-bearing women can be enrolled if adequate contraceptive precautions are used before entering this trial and for the duration of the trial;

• Concerns for patient's compliance with the protocol procedures.